Diabetes mellitus is a chronic disease that affects the lives of millions of people in the United States and around the World. Many diabetics will develop a serious foot conditions at some time in their lives, which in some cases require toe amputations or even amputations of the entire foot. High blood sugar levels also affect the body's immune system and delays wound healing.
Neuropathy is an impairment that affects about half of those with diabetes, and causes loss of feeling in feet, which increases the risk of undetected injury. Diabetics suffering from neuropathy can unknowingly develop minor cuts or scrapes, blisters, or pressure sores due to the feeling insensitivity. If such minor injuries are left untreated or fail to heal, complications may lead to ulceration, infection, and gangrene. In fact, diabetic foot complications are the most common cause of non-traumatic lower extremity amputations in the United States. The risk of lower extremity amputation has been estimated to be about 15 to 46 times higher in diabetics than in non-diabetics. Importantly, the majority of diabetic foot complications begin with the formation of skin ulcers on the bottom of the foot.
Specially designed footwear for diabetics as well as other orthopedic devices can reduce the risk of many foot complications, such as the formation of calluses, foot ulcers, poor circulation, decreased resistance to infection, foot deformities, and neuropathy, that are especially problematic for diabetics.
Custom orthopedic footwear for diabetics often has a relatively rigid, resilient base comprising a heel portion and an arch portion, which are contoured to fit the plantar or bottom surface of the foot. Unfortunately, most customized prescription orthopedic footwear and/or footwear devices for diabetics require the preparation of molds for the feet and subsequent manufacturing of the footwear and/or devices with a significant delay of many weeks between the measuring of feet for an orthopedic shoe or device and the arrival of the new customized device, such as insoles as well as footwear. The custom insoles are generally created from hard plastics by making a mold that is based upon detailed foot measurements, and is then modified as needed to provide prescribed corrections by a podiatrist. Custom orthopedic footwear may also be unattractive and the footwear will not be as versatile as insoles that can be placed within ordinary shoes and other footwear.
Conventional footwear inserts or soles that may consist of materials such as rigid plastic and/or elastomeric foam with an impact cushioning foam layer or space filler, usually provide insufficient foot protection and/or do not address the different needs of the various areas of the foot, which can be unique to wearers. The insoles often do not provide enough protection or support for proper biomechanical functions of the foot, particularly in the rear foot area, and in the arch areas of the foot. Also, conventional insoles typically do not hold a wearer's heel in place and also provide arch support, as well as allow certain movement of the foot such as in the toe area that allows the toes to slide and move. Thus, such conventional inserts and soles are often ineffective in preventing or alleviating foot conditions experienced by diabetics and other persons with foot problems.
Special footwear and/or footwear components and devices are considered one of the best ways to prevent the aforementioned problems of diabetics and others. It is also believed that many foot and toe complications of non-diabetics could be prevented through the use of the insoles of this invention. In an embodiment, the insole has sections that are for a variety of foot shapes and that can be customized for a variety of wearers and wear requirements. Also if desired, one or more of the sections can have different cushioning and/or surface characteristics.